LY303366 DOSE RANGING EFFICACY AND SAFETY STUDY IN ORAL CANDIDIASIS

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This is a randomized, double-blind, multicenter evaluation of the safety and efficacy of three orally administered 1-week dosage regimens of LY303366 and a reference regimen of orally administered fluconazole for 2 weeks in the treatment of patients with oral candidiasis co-infected with HIV. Approximately 160 patients will be randomized to provide approximately 128 patients who qualify for efficacy analysis. Patients who have met the entry criteria and have signed and informed consent document will be randomly assigned to on of the four treatmen groups. The posttherapy follow-up period will b 3 or 2 weeks, if randomized to an LY303366 regimen for fluconazole regimen, respectivly. An interim analysis is planned when data from at least 48 qualified patients (approximatley 12 patients in each regimen) have been validated. One or more treatment regimens may be deleted following the interim analyses. Deletion of a treatment regimen will not affect patients who are already being treated with that regimen.